Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
NCT ID: NCT03458871
Last Updated: 2021-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-03-13
2019-02-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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4-week TTNS home based protocol
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol
4-week TTNS home-based protocol. Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is not contraction seen, maximal tolerable intensity will be used.
In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
Interventions
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4-week TTNS home-based protocol
4-week TTNS home-based protocol. Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is not contraction seen, maximal tolerable intensity will be used.
In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
Eligibility Criteria
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Inclusion Criteria
* Neurologically stable SCI for ≥ 6 months
* Intermittent catheterization to empty bladder
* Stable bladder medications for ≥ 3 months
Exclusion Criteria
* Other diagnoses to explain incontinence (ex: UTI, bladder stones, multiple sclerosis, etc.)
* 2+ pitting edema that does not resolve
* Known peripheral neuropathy or injury to the path of the tibial nerve
* Demand-type cardiac pacemaker or implanted defibrillator
* Cancer in the tibial nerve path and/or bladder
* Inability to elicit toe/plantar flexion with electric stimulation during the clinic visit.
* Inability to understand directions
* Non-English speaking
18 Years
65 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Argyrios Stampas, MD
Assistant Professor
Principal Investigators
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Argyrios Stampas, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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Stampas A, Korupolu R, Lee KH, Salazar B, Khavari R. Reduction of Overactive Bladder Medications in Spinal Cord Injury With Self-Administered Neuromodulation: A Randomized Trial. J Urol. 2024 Dec;212(6):800-810. doi: 10.1097/JU.0000000000004189. Epub 2024 Aug 2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-17-0423
Identifier Type: -
Identifier Source: org_study_id